Q&A: Ethics of disclosing seemingly harmless adverse events

For large-scale adverse events affecting tens or thousands of patients, is disclosure ethical if patients are unlikely to have been physically harmed by the event but could be harmed psychologically by the disclosure? An interview with the lead author of a recent study examined the ethics of reporting events.

In the study, Denise M. Dudzinski, PhD, and colleagues from the University of Washington School of Medicine in Seattle, outlined tips for reporting such large-scale adverse events. Interestingly, they encourage organizations to be media savvy because there will inevitably be coverage of the aftermath.

These events, which can result from incompletely sterilized surgical equipment, poor laboratory quality control or equipment malfunctions, are often identified after care has been provided.

Dudzinski, an associate professor in the department of bioethics and humanities, and the chief of the ethics consultation service at University of Washington, spoke further about the ethics of reporting these multiple adverse events.

At the University of Washington, do you have disclosure coaches, clinicians trained to advise other clinicians on how to disclose and apologize to patients when there has been an adverse event?

Dudzinski: We do use a disclosure-coaching model at the University of Washington. Most of the disclosure coaches are risk managers, who have received specific training from a group led by Dr. Tom Gallagher, (a co-author of the study).

The University of Washington also has trained others in leadership roles to serve as disclosure coaches, such as department chairs, medical directors and nurse managers. The disclosure-coaching model has been extremely well received, and clinicians are grateful for the ability to have just-in-time support through the disclosure process.

What is the distinction between medical errors and adverse events?

Dudzinski: The Institute of Medicine defines an adverse event as "an injury resulting from a medical intervention" and an error as "failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim." Our study pertained to adverse events—injuries due to medical intervention. Some adverse events are errors, but many are not. We define large-scale adverse events as "events that increase the risk that multiple patients will be injured due to healthcare management, whether the increased risk was related to accidents, breakdowns or errors." In all cases, we advocate disclosure.

What are the differences in the way a facility informs one individual about a medical error or adverse event and how that facility informs hundreds?

Dudzinski: The disclosure conversation between a provider and an individual patient almost always is a face-to-face discussion. For many large-scale adverse events, especially when the likelihood is low that any patients were physically harmed, an initial communication via a letter is more practical, as long as patients are provided an easy option whereby they can discuss any concerns they may have directly with an institutional official.

However, in a large-scale adverse event scenario where the probability and severity of harm is higher, such as the Canadian Hormone Receptor Testing case discussed in our paper, the initial notification should be conducted personally rather than in writing, and should be carried out at the same time for all affected patients.

Personally notifying large numbers of patients presents significant logistical challenges, but these can be solved with appropriate resource application by the institution.

Perhaps there can be a "two-way" consent form where the patient consents to the procedure and the hospital/physician consents to informing the patient of any errors or adverse events.

Dudzinski: Informed consent pertains only to patients, not providers. Still, in some ways, a large-scale adverse event disclosure policy, which we recommend, is the institutional corollary of consent. The policy spells out the obligations and standards the facility will use to responsibly address large-scale adverse events.

What is the economic case to be made for hospitals to adopt a policy of full disclosure?

Dudzinski: Disclosure, follow-up testing and treatment can be expensive, but may be economically sound in the long run by helping to maintain the public trust. Hospitals that are seen as honest and demonstrating integrity may fare better after these crises.

Though our study focused on the ethical, not economic, impact of disclosure, we identify cost as a consideration in the harms/benefits analysis and conclude that disclosure is warranted even when it is financially costly.